BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REGENEREX RINGLOC + ACETABULAR CUP

    MDR report key: 1082310 · Received July 29, 2008

    Report

    Report Number
    1825034-2008-00202
    Event Type
    Injury
    Date Received
    July 29, 2008
    Date of Event
    June 26, 2008
    Report Date
    June 30, 2008
    Manufacturer
    BIOMET INC.
    Product Code
    LPH
    PMA / PMN Number
    K070369
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR. THERE HAVE BEEN NO TRENDS IDENTIFIED RELATED TO THIS TYPE OF EVENT. EVALUATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCES. EXAMINATION OF RETURNED DEVICE WAS INCONCLUSIVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT HIP ARTHROPLASTY PROCEDURE IN 2008. AT TWO (2) WEEK FOLLOW UP VISIT, RADIOGRAPHS SHOWED THE LINER AND SHELL DISASSOCIATED AND THE LOCKING RING WAS LOOSE. SUBSEQUENTLY, REVISION PROCEDURE WAS PERFORMED TWO WEEKS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REGENEREX RINGLOC + ACETABULAR CUP PROSTHESIS, HIP COMPONENT LPH BIOMET INC. N/A 152220

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R